Clinical Trial Norms Diluted For AYUSH Drugs, Says Amicus; Supreme Court Seeks Centre's Response

The Supreme Court of India has asked the central government to provide an explanation regarding the dilution of clinical trial rules for AYUSH (Ayurveda, Yoga, Unani, Siddha, and Homeopathy) drugs. The Court's direction followed concerns raised by an amicus curiae about potential impacts on patient safety and efficacy due to relaxed regulations. The Court is scrutinizing amendments made to clinical trial norms for AYUSH drugs, which were reportedly softened to expedite drug approvals. The government has been requested to clarify the rationale behind these changes and to address concerns about maintaining rigorous standards in drug testing and approval processes.